iFR vs FFR-guided coronary revascularization - PowerPoint Presentation

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iFR vs FFR-guided coronary revascularizationiFR-Swedeheart 5-year outcome

Matthias Götberg, MD, PhDSkane University Hospital, Lund University, Sweden- on behalf of the iFR-Swedeheart investigators

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship

Company

Grant/Research Support

Boston Scientific, Philips HealthcareConsulting Fees/HonorariaAbbott, Boston Scientific, Medtronic

Disclosure Statement of Financial Interest

Faculty disclosure information can be found on the app

BackgroundInstantaneous Wa

ve-free ratio (iFR) is a non-hyperemic (resting) index for assessment of coronary lesion severityPrevious validation studies have demonstrated similar or improved ability to accurately detect ischemia compared with Fractional Flow Reserve (FFR)

Sen S et al. Circ. Int. 2014;7:492-502, van de

Hoef

TP et al. Circ Cardiovasc Interv. 2012;5:508-14de Waard G et al. J Am Coll Cardiol. 2014;63:A1692

Study Design iFR-Swedeheart

Hypothesis :

iFR

is non-inferior to FFR at 1 year regarding a composite of all-cause death, MI, and unplanned revascularization

Non-inferiority margin of 1.4 (3.2%) (upper 1-sided 97.5% CI)2000 patients with 85% power to test hypothesisPrimary endpoint at 1 yearFinal follow-up at 5 yearsFinal follow-up at 5 years

Study Design iFR-Swedeheart

Registry based Randomized Clinical Trial (RRCT)Trial design utilizing national quality registers as an electronic CRF:baseline characteristicsdata-inputonline randomizationfollow-upProven pragmatic and cost-effective trial design facilitated by use of unique personal identifiers in Scandinavia allowing for 100% tracking of patients

Major inclusion and exclusion criteriaPatients with suspected stable angina pectoris or unstable angina pectoris/NSTEMI

A clinical indication for physiology-guided assessment of coronary lesions (30-80% stenosis grade)Known terminal disease with a life expectancy <1 yearUnstable hemodynamics (Killip class III-IV)Inability to tolerate adenosinePrevious CABG with patent graft to the interrogated vessel

Heavily calcified or tortuous vessel where inability to cross the lesion with a pressure wire was expected

Previous randomization in

iFR-SWEDEHEART trial

Lund/MalmöHelsingborg

HalmstadKalmarGöteborgLinköping

Örebro

St

GöranUppsalaVästeråsKarlstadSundsvallAarhus (Denmark)Reykjavik (Iceland)

Steering committee

Matthias

Götberg

(PI)

Evald

H. Christiansen

David

Erlinge

Elmir

Omerovic

Stefan K. James

Ole

Fröbert

(chairman)

15 Participating sites in Scandinavia

Enrollment

2037 patients enrolled between May 2014- Oct 2015

No patients were lost to follow-up

Baseline clinical characteristics

Procedural characteristics

More lesions evaluated in

iFR

-group but fewer significant lesions

Procedural characteristics (ii)

More stents deployed in FFR-group

Primary Composite Endpoint at 12 months all-cause death

, MI, unplanned revascularization

Götberg et al.

N

Engl J Med 2017; 376:1813-1823iFR was non-inferior to FFR regarding primary composite endpoint at 12 months

Composite Endpoint at 5 yearsall-cause death, MI, unplanned

revascularizationiFR

no difference in composite outcome compared with FFR at 5 years

iFR

21.5%FFR 19.9%HR 1.09; 95% CI: 0.90, 1.33

All-cause mortality at 5 years

iFR no difference in all-cause mortality compared with FFR

iFR

9.4%

FFR 7.9%HR 1.20; 95% CI: 0.89, 1.62

Myocardial infarction at 5 years

iFR no difference in non-fatal myocardial infarction compared with FFR

iFR

5.8%

FFR 5.7%HR 1.00; 95% CI: 0.70, 1.44

Unplanned revascularization at 5 years

iFR no difference in unplanned revascularization compared with FFR

iFR

11.6%

FFR 11.3%HR 1.02; 95% CI: 0.79, 1.32

Composite endpoint at 5-yearsSubgroup analysis

No difference in outcome in any of the pre-specified subgroups

Summary iFR-Swedeheart

In patients with stable angina or acute coronary syndromeiFR provides no difference in outcome at 5-years compared with FFRThe composite endpoint (all-cause death, MI, unplanned revasc) All-cause deathNon-fatal myocardial infarctionUnplanned revascularization

Composite endpoint in pre-specified subgroups

Conclusions

The 5-year follow-up of iFR-SWEDEHEART showed no difference in outcome, confirming the long-term safety and efficacy of revascularization guided by iFR compared with FFR